5-Hour Energy: Adverse event reports do not prove that our shots caused 13 deaths

While smaller players have attempted to attract younger consumers, 5-hour Energy’s success has been in large part down to its ability to appeal to office workers and older consumers trying to stay alert, say experts

5-Hour Energy is “unaware of any deaths proven to have been caused” by consuming its top-selling energy shots, distributor Living Essentials has insisted, after the FDA confirmed it has received 92 serious adverse event reports (AERs) citing 5-Hour-Energy in four years, including 33 hospitalizations and 13 deaths.

To put these figures into perspective, company spokeswoman Elaine Lutz told FoodNavigator-USA that the firm now sells more than nine million bottles of 5-Hour Energy every week, and stressed that adverse event reports do not prove causality.

5-Hour Energy: We sell 9 million bottles a week

Each bottle of 5-Hour Energy, which accounted for nine out of every $10 spent in the energy shots category last year, contains “about as much caffeine as a cup of the leading premium coffee”, and contains no herbal stimulants such as guarana or yohimbe, added Lutz in a statement.

However, consumers with caffeine sensitivities “should consult with a physician before taking” or opt for the decaf variant, she said.

It is not an energy drink, nor marketed as a beverage. In direct contrast to other products on the market, 5-hour Energy is not marketed for use with alcohol... When consumed according to our recommended use guidelines, 5-hour Energy is an effective dietary supplement.

“We recommend on product labels and the website that individuals consume no more than two bottles per day, spaced several hours apart. We also recommend individuals new to 5-hour Energy try half a bottle to start, wait 10 minutes and consume the rest later.”

FDA: Energy shots and drinks are not alternatives to rest or sleep

The FDA said it is “continuing to investigate reports of illness, injury or death” from people consuming the shot, but told FoodNavigator-USA that the “existence of an adverse event report (AER) does not necessarily mean that the product identified in the report actually caused the adverse event”.

A spokeswoman added: “FDA as a scientific public health agency must carefully investigate and evaluate all possible causes before deciding whether the product actually caused the medical problem.”

In the meantime, “FDA cautions consumers that 5-Hour Energy and other products marketed as energy shots or energy drinks are not alternatives to rest or sleep”, she said.

Consumers that are concerned “should consult with their health care provider to ensure that there are no underlying or undiagnosed medical conditions that could worsen as a result of using them”, she added.

Broadening the scope of AER reporting would not benefit the industry or consumers

The FDA, which is also investigating reports into fatalities adverse event reports connected to Monster Energy, is under pressure to make adverse event reports about dietary supplements public, although some commentators believe this could prove unduly alarmist and encourage frivolous lawsuits.

Speaking at the Supply Side West show last week, Council for Responsible Nutrition government relations VP Mike Greene said a new Government Accountability Office (GAO) report on AERs would probably be published in late February or early March - and would not likely make pleasant reading for the trade.

While a 2009 GAO report had raised concerns about under-reporting of AERs in the supplement sector, the reason the numbers were so low was a reflection of the overall safety record of dietary supplements, rather than proof that the system wasn’t working, he claimed.

And while it is critical for the FDA to be alerted to serious adverse events linked to supplements, it would not be in the best interests of consumers to broaden the scope of adverse event reporting to include more minor issues, added Patricia Knight, senior policy advisor for the United Natural Products Alliance.

“We’ve pushed back at [previous] attempts to broaden the scope of AER reporting because you just end up with a lot of white noise.”

The American Herbal Products Association (AHPA) said it had not yet reviewed the AERs in question but “notes that AERs report associations only and are not evidence of nor admission of a causal relationship between the product and the adverse events reported.”

Durbin: It’s unclear how the AER system is working in practice

However, Senator Richard Durbin (D-IL) - who has repeatedly raised concerns about energy shots and drinks - has been pushing for greater transparency in the AER reporting system.

In a letter to the Comptroller General of the US sent in November 2011, Durbin said it was “unclear how the AER system is working on practice”, and asked the GAO to explore the number and severity of supplement-related AERs, what steps the FDA is taking to ensure manufacturers are reporting adverse events, and how the agency is using AER data it collates to protect consumers.    

Dr Fabricant: ‘Some pretty good indications of under-reporting of adverse events’

Speaking at a webinar on cGMP compliance organized by the Natural Products Association (NPA) in April, FDA dietary supplements division head Dr Dan Fabricant said there were “some pretty good indications” of under-reporting of adverse events.  

Moreover, several firms were still failing to provide a domestic address and contact number for consumers to call to report adverse effects, making it doubly unlikely that they were being properly recorded, he claimed.

5-Hour-Energy contains a blend of caffeine, taurine, glucuronolactone, malic acid, N-Acetyl L-tyrosine, L-phenylalanine and citicoline, plus vitamin B12, vitamin B6, folic acid and Niacin.

Related News

Durbin seeks meeting with FDA following 5-Hour adverse events news

Durbin seeks meeting with FDA following 5-Hour adverse events news

Caffeine claims may be on the way in the EU, despite strong opposition

EC-member states moving toward caffeine health claim consensus

Senators Durbin and Blumenthal want to put the energy drinks industry firmly inside its box...

Senators tilt at Red Bull as FDA hints at energy action

Picture Copyright: Inazakira/Flickr

5-Hour Energy ‘misled public’ as to our product safety stance: CSPI

Senator Dick Durbin argues that firms are continuing to market energy drinks as liquid dietary supplements in order to circumvent rules about caffeine content.

Majority of caffeine-containing supplements have inaccurate labels, claims study

Packaging helps drive success in point-of-purchase marketplace

Packaging helps drive success in point-of-purchase marketplace

AERs – A unique opportunity to build confidence in supplements: SafetyCall

AERs – A unique opportunity to build confidence in supplements: SafetyCall

Picture Credit: Inazikira/Flickr

Eye-catching study suggests 5-Hour Energy boost barely beats caffeine alone

The Toxicology Forum met at the St. Regis Hotel in Aspen.

Complexity of supplements hampers adverse events reporting, experts say

Bucchini: "We need EFSA to be able to assess botanicals, but more discriminatory power is necessary."

EFSA’s yohimbe aphrodisiac assessment ‘interesting and surprising’: EU herbal expert

© iStock / memoriesarecaptured

Guilty verdict in 5-hour counterfeiting case seen as potent deterrent

Dr. Rick Kingston of the University of Minnesota and SafetyCall International spoke at a scientific conference in Oxford, MS.  NutraIngredients-USA photo.

Adverse events database not useful for drawing safety conclusions, expert says

5-hour Energy accounts for 90% of the energy shots market

5-hour Energy increases grip on energy shots market

Almost nine out of every $10 spent on energy shots goes into 5-Hour Energy's coffers

5-Hour Energy ramps up from seven to nine million bottles a week

New kid on the block: On Point Energy

Energy shots special edition: Flash in the pan or the runaway success story of the decade?

Related Products

See more related products

Comments (1)

Paul Kemp - 19 Nov 2012 | 06:20

I Smell Blood in the Water RE: 5-Hour Energy AERs

I have been watching 5-Hour Energy's market dominations from the point of view of a competitor, waiting for this giant success to be revealed as based on clever advertising and an overpriced product. No, 13 deaths and 33 hospitalizations don't prove causation, but they will certainly make many buyers wonder if there are better alternatives.

19-Nov-2012 at 18:20 GMT

Submit a comment

Your comment has been saved

Post a comment

Please note that any information that you supply is protected by our Privacy and Cookie Policy. Access to all documents and request for further information are available to all users at no costs, In order to provide you with this free service, William Reed Business Media SAS does share your information with companies that have content on this site. When you access a document or request further information from this site, your information maybe shared with the owners of that document or information.